Registration Dossier
Registration Dossier
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EC number: 249-044-4 | CAS number: 28472-97-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions; analytical purity of test material not specified
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- analytical purity of test material not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diisodecyl azelate
- EC Number:
- 249-044-4
- EC Name:
- Diisodecyl azelate
- Cas Number:
- 28472-97-1
- Molecular formula:
- Main component: C29H56O4
- IUPAC Name:
- C9-11 branched alcohols , C10 rich diesters with nonanedioic acid
- Details on test material:
- - Name of test material (as cited in study report): Diisodecyl azelate
- Physical state: clear yellow liquid
- Analytical purity: not indicated by the sponsor; treated as 100% pure
- Lot/batch No.: 033175
- Expiration date of the lot/batch: 30 Nov 2011
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- Density: 0.91 g/mL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 11-12 weeks
- Weight at study initiation: mean for males 323 g, mean for females 210 g, body weight variation did not exceed ± 20% of the sex mean
- Housing: individually housed in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 05 Jan 2010 To: 19 Jan 2010
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 25 cm² for males and 18 cm² for females
- % coverage: 10
- Type of wrap if used: surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage, a piece of Micropore tape was additionally used for fixation of the bandages in females only
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test substance was removed with tap water.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.20 mL/kg bw
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality/Viability: Twice daily; Body weights: Days 1 (pre-administration), 8 and 15; Clinical signs: at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Flat posture and/or chromodacryorrhoea was observed among several animals on Day 1. Scales were seen in the treated skin-area of several animals between Days 4 and 13.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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